Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01757717
First received: December 19, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately.

This method, called "image-guided surgical navigation" may allow the doctors to deliver the radiation to the spinal tumor that you need and decrease the amount of radiation delivered to the spinal cord.


Condition Intervention
Metastatic or Recurrent Lesions in the Spine
Radiation: Ir-192 high dose rate (HDR)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • feasibility of High Dose Rate (HDR) treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    of spine lesions using catheters placed under image guided navigational techniques, to provide improved dosimetric coverage of spinal lesions such that.

    In terms of technical feasibility, a patient is regarded as being successfully treated if the target D90 is ≥ 80% AND the cord/cauda max dose is 8 Gy.



Secondary Outcome Measures:
  • Toxicity of HDR brachytherapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    for previously irradiated lesions of the spine, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ir-192 high dose rate (HDR)
This pilot study is an investigation into the use of Ir-192 high dose rate (HDR) afterloader-based brachytherapy with catheter placement using image-guided surgical navigation techniques for patients with painful/symptomatic metastatic or recurrent lesions in the spine that have been maximally treated with external beam radiation therapy.
Radiation: Ir-192 high dose rate (HDR)
Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic proof of a malignancy suitable for radiation therapy.
  • Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, kidneys, rectum) will be taken into consideration.
  • If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible.
  • If the total prior radiation dose to the cord exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. [Rades 2005, Nieder 2005, Sahgal 2012]
  • KPS ≥ 60
  • Age ≥ 18 years old

Exclusion Criteria:

  • Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria.
  • Patients with kyphoplasty cement or hardware that would preclude effective catheter placement.
  • Patients with paraspinal extension of disease with visceral involvement.
  • Abnormal complete blood count. Any of the following:
  • Platelet count < 75,000/ml
  • Hb level < 9gm/dl
  • WBC < 3.5/ml
  • Abnormal coagulation profile: INR > 2.5 and/or PTT > 80
  • Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
  • Contraindications to general anesthesia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757717

Contacts
Contact: Yoshiya Yamada, MD 212-639-2950
Contact: Mark Bilsky, MD 212-639-8526

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Yoshiya Yamada, MD    212-639-2950      
Contact: Mark Bilsky, MD    212-639-8526      
Principal Investigator: Yoshiya Yamada, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Yoshiya Yamada, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01757717     History of Changes
Other Study ID Numbers: 12-260
Study First Received: December 19, 2012
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
radiation therapy
HDR brachytherapy
Ir-192 high dose rate
12-260

ClinicalTrials.gov processed this record on August 28, 2014